Large

We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market. It involves utilizing technology, data, and human expertise. It is a big challenge that requires diverse talents. Our model involves both nurturing and investing organically and acquiring capabilities that we do not have but critically need. Our core executive team is anchored to this model, building life science services that address fundamental changes in healthcare that are necessary for health and outcomes improvement.


Science & Healthcare

Precision Medicine Group

You need a relevant degree, 5-7 years in regulatory affairs, experience with clinical submissions, knowledge of drug development and regulations, and availability for travel.

You will provide regulatory guidance, review submissions, lead project teams, oversee specialists, maintain project plans, and ensure compliance with drug development regulations.

Healthcare

Madrid

<div>Precision for Medicine are recruiting a Regulatory Manager to join our team, candidates can be based in the following countries: UK, Spain, Hungary, Slovakia, Serbia, Romania or Poland.

The Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The Regulatory Manager coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable.

Essential functions of the job include but are not limited to:
<ul>
<li>Provides regulatory guidance throughout the clinical development life cycle</li>
<li>Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as required</li>
<li>Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards</li>
<li>Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers</li>
<li>Works within a project team, and where necessary, leads project for the region or globally</li>
<li>Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs</li>
<li>Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.</li>
<li>Assist in development of Regulatory Affairs Specialists and other operational area staff, as required</li>
<li>Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information</li>
<li>Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.</li>
<li>Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval</li>
<li>Provides ICH GCP guidance, advice and training to internal and external clients</li>
<li>Serve as representative of Global Regulatory Affairs at business development meetings</li>
</ul>
Qualifications:

Minimum Required:
<ul>
<li>Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline</li>
<li>5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level</li>
<li>Computer literacy (MS Office/ Office 365)</li>
<li>Fluent in English</li>
</ul>
Preferred:
<ul>
<li>Graduate, postgraduate</li>
<li>Possesses basic understanding of financial management</li>
</ul>
Other Required:

Candidates must have regulatory affairs experience working for a Clinical Research Organisation and have experience leading Clinical Submissions

Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions.
<ul>
<li>Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy</li>
<li>Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied</li>
<li>Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development</li>
<li>Availability for domestic and international travel including overnight stays</li>
</ul>
Competencies
<ul>
<li>Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities</li>
<li>Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates</li>
<li>Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills</li>
<li>Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment</li>
<li>Motivates other members of the project team to meet timelines and project goals</li>
<li>Flexible attitude with respect to work assignments, and new learning</li>
<li>Resolves project related problems and prioritize workload to meet deadlines with little support from management</li>
<li>Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective</li>
<li>Collects data of consistently high standard</li>
<li>Communicates effectively in the English language both verbally and in written form</li>
<li>Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency</li>
</ul>
#LI-OS1 #LI-Remote

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

About Precision for Medicine:

Precision for Medicine is a precision medicine Clinical Research Organization. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.

Precision medicine is revolutionizing the attack on cancer&mdash;and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions&mdash;and optimize the oncology development pathway.
<div>
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. &copy; 2020 Precision Medicine Group, LLC

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.</div></div>

Precision for Medicine are recruiting a Regulatory Manager to join our team, candidates can be based in the following countries: UK, Spain, Hungary, Slovakia, Serbia, Romania or Poland.

The Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The Regulatory Manager coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable.

Essential functions of the job include but are not limited to:

Provides regulatory guidance throughout the clinical development life cycle
Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as required
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
Works within a project team, and where necessary, leads project for the region or globally
Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
Assist in development of Regulatory Affairs Specialists and other operational area staff, as required
Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information
Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.
Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval
Provides ICH GCP guidance, advice and training to internal and external clients
Serve as representative of Global Regulatory Affairs at business development meetings

Qualifications:

Minimum Required:

Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level
Computer literacy (MS Office/ Office 365)
Fluent in English

Preferred:

Graduate, postgraduate
Possesses basic understanding of financial management

Other Required:

Candidates must have regulatory affairs experience working for a Clinical Research Organisation and have experience leading Clinical Submissions

Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions.

Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied
Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
Availability for domestic and international travel including overnight stays

Competencies

Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities
Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates
Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment
Motivates other members of the project team to meet timelines and project goals
Flexible attitude with respect to work assignments, and new learning
Resolves project related problems and prioritize workload to meet deadlines with little support from management
Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
Collects data of consistently high standard
Communicates effectively in the English language both verbally and in written form
Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency

#LI-OS1 #LI-Remote

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

About Precision for Medicine:

Precision for Medicine is a precision medicine Clinical Research Organization. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.

Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Precision Medicine Group

Mission